Regulatory Data Steward

Role Summary

The Regulatory Data Steward plays a key role in ensuring the quality, integrity, and compliance of regulatory data within the Company’s Regulatory Information Management (RIM) ecosystem. This role combines hands-on data analysis and remediation with governance execution, supporting both operational data quality oversight and strategic regulatory compliance needs. The successful candidate will leverage strong data analysis skills, expertise in regulatory data standards, and knowledge of regulatory processes to safeguard master and transactional data. This position provides the opportunity to work across multiple functions and systems, integrating internal and external data assets into RIM platforms, while ensuring alignment with international regulations and the Company’s data governance framework. Location: Massachusetts - Virtual.

Responsibilities

• Monitor, profile, and analyze regulatory data to ensure compliance with defined standards and design specifications (source-to-target validation).
• Perform data quality analysis, error detection, documentation, and correction across diverse platforms (SQL, Excel, Informatica, Veeva Vault, third-party applications).
• Investigate, troubleshoot, and document data issues raised by internal and external stakeholders.
• Support root-cause analysis of data issues and recommend process and system improvements.
• Ensure sensitive data is always protected through approved controls and practices.

Qualifications

• Required: 5+ years of experience in the healthcare/pharmaceutical industry.
• Required: 5+ years of experience in data management or data governance roles, ideally in a regulatory context.
• Required: Bachelor’s degree in Life Sciences, Pharmacy, Data Science, Information Management, or a related field.
• Preferred: Master’s degree in Regulatory Affairs, Data Management, or related discipline.
• Required: Strong expertise with the Veeva RIM data model and regulatory metadata management.
• Required: In-depth understanding of regulatory data standards (IDMP, SPOR, XEVMPD, eCTD, etc.).
• Required: Strong analytical and problem-solving skills, including root-cause analysis and remediation.
• Required: Hands-on experience with SQL, Excel, and reporting/visualization tools (Power BI, Tableau, or equivalent).
• Required: Experience working in GxP environments and familiarity with data privacy regulations.
• Required: Ability to work independently with minimal oversight, while influencing diverse stakeholders.
• Required: Excellent communication skills, with the ability to translate technical data concepts into business terms.
• Required: Experience with regulatory domains such as Labeling, CMC, and broader Regulatory Affairs processes.
• Required: Exposure to public and hybrid cloud environments.
• Preferred: Experience supporting large-scale data remediation, migration, or M&A integration projects.
• Preferred: Experience working with outsourced data stewardship vendors or data service providers.
• Preferred: Knowledge of emerging regulatory frameworks (ePI, ESMP, PQ/CMC).
• Preferred: Familiarity with data quality and governance tools (e.g., Informatica, Collibra, or equivalent).
• Preferred: Change management or process improvement certification (e.g., Lean, Six Sigma, PROSCI).
• Preferred: Proven ability to influence without authority and drive adoption of governance processes.

Education

• Bachelor’s degree in Life Sciences, Pharmacy, Data Science, Information Management, or a related field
• Master’s degree in Regulatory Affairs, Data Management, or related discipline (preferred)

Skills

• SQL
• Excel
• Power BI or Tableau
• Regulatory data standards and governance
• Data quality management
• Communication of technical concepts to business stakeholders